Ignite Creation Date:
2024-05-06 @ 12:29 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03775226
Status:
TERMINATED
Last Update Posted:
2023-10-03
First Post:
2018-11-21
Brief Title:
ChampioNIR SFA Stent EFS Study
Sponsor:
Medinol Ltd
Organization:
Medinol Ltd
Study Overview
Official Title:
An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR SFA Stent in the Treatment of Patients With Femoro-Popliteal Disease
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study objective was achieved Patients are no longer being examined or receiving intervention
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR SFA Stent in the Treatment of Patients with Femoro-Popliteal Disease
Detailed Description:
Device Overview
The ChampioNIR SFA Stent is composed of a Nitinol alloy structure with an elastomeric micro-fiber mesh and is designed specifically to be used in the peripheral vasculature The stent is characterized by high flexibility strong radial support and high resistance to fractures as well as high deliverability and precise positioning
Objectives
To assess the safety and feasibility of delivery and implantation of ChampioNIR SFA Stent
To assess the early and long term ability of the stent to maintain vessel patency
To assess the long term safety of the ChampioNIR SFA Stent
This study is designed as an early feasibility prospective open label single arm study 30 patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be treated with ChampioNIR SFA stent implantation All enrolled patients will be followed up at 30 days and up to 36 months The follow-up visits will include patency evaluation by duplex ultrasound
Primary efficacy endpoint Primary patency of the target lesion at 6 months Primary patency is defined as the absence of target lesion restenosis defined by Duplex ultrasound US peak systolic velocity ratio PSVR 24 Primary safety endpoint Composite rate of freedom from all-cause death target vessel revascularization or any amputation of the index limb through 30 days following stent implantation
Secondary efficacy endpoints
1 Primary patency defined by Duplex US peak systolic velocity ratio absence of restenosis which defined by Duplex US PSVR 24 at 30 days and 12 months
2 Acute device success defined as achievement of a final residual diameter stenosis of 50 by Quantitative Angiography QA using the assigned treatment only
3 Acute procedural success defined as device success with 50 residual stenosis immediately after stent placement or mean trans-stenotic pressure gradient 5 mmHg and without the occurrence of death amputation or repeat revascularization of the target lesion during the hospital stay
4 Acute technical success defined as the attainment of 50 residual stenosis by QA by any percutaneous method as determined by the angiographic core laboratory
5 The following endpoints at 30 days 6 12 24 and 36 months
Secondary Patency absence of restenosis which is defined as Duplex US PSVR 24
Change of Rutherford classification from baseline
Change of resting ankle-brachial index ABI from baseline
Change in walking impairment questionnaire from baseline
Change in six minute walk test from baseline
Secondary safety endpoints
1 Combined rate of death at 30 days target lesion revascularization TVR index limb amputation and increase in Rutherford-Becker Classification by 2 classes as compared to post-procedural assessment throughout 12 months
2 Stent fracture at 30 days 6 12 24 and 36 months Stent fractures will be analyzed by a two-view X-ray evaluation by a designated core laboratory compared with a baseline two-view X-ray taken before discharge and defined as type I II III IV or V as follows
Type I - a single strut fracture only
Type II - multiple single nitinol stent fractures that can occur at different sites
Type III - multiple nitinol stent fractures resulting in complete transverse linear fracture but without stent displacement
Type IV - a complete transverse linear type III fracture with stent displacement
Type V - a spiral dissection of a stent
3 Freedom at 30 days from all-cause death index limb amputation above the ankle and TVR
4 The following endpoints will be assessed at 30 days 6 12 24 and 36 months
1 All-cause death
2 Amputation above the ankle-Free Survival AFS
3 Target Vessel Revascularization TVR
4 Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature
5 Major Adverse Limb Events MALE at 30 days 6 12 24 and 36 months
1 Stent thrombosis
2 Clinically apparent distal embolization defined as causing end-organ damage eg lower extremity ulceration tissue necrosis or gangrene
3 Procedure-related arterial rupture
4 Acute limb ischemia
5 Target limb amputation
6 Procedure related bleeding event requiring transfusion
Sample Size and Statistical Analysis
The study is an early feasibility study and is not powered towards finding significant differences in the primary endpoints The sample size of up to 30 patients will allow for the evaluation of feasibility and safety of the procedure to support the initiation of a pivotal study No formal statistical power calculations were conducted
The ChampioNIR SFA Stent is composed of a Nitinol alloy structure with an elastomeric micro-fiber mesh and is designed specifically to be used in the peripheral vasculature The stent is characterized by high flexibility strong radial support and high resistance to fractures as well as high deliverability and precise positioning
Objectives
To assess the safety and feasibility of delivery and implantation of ChampioNIR SFA Stent
To assess the early and long term ability of the stent to maintain vessel patency
To assess the long term safety of the ChampioNIR SFA Stent
This study is designed as an early feasibility prospective open label single arm study 30 patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be treated with ChampioNIR SFA stent implantation All enrolled patients will be followed up at 30 days and up to 36 months The follow-up visits will include patency evaluation by duplex ultrasound
Primary efficacy endpoint Primary patency of the target lesion at 6 months Primary patency is defined as the absence of target lesion restenosis defined by Duplex ultrasound US peak systolic velocity ratio PSVR 24 Primary safety endpoint Composite rate of freedom from all-cause death target vessel revascularization or any amputation of the index limb through 30 days following stent implantation
Secondary efficacy endpoints
1 Primary patency defined by Duplex US peak systolic velocity ratio absence of restenosis which defined by Duplex US PSVR 24 at 30 days and 12 months
2 Acute device success defined as achievement of a final residual diameter stenosis of 50 by Quantitative Angiography QA using the assigned treatment only
3 Acute procedural success defined as device success with 50 residual stenosis immediately after stent placement or mean trans-stenotic pressure gradient 5 mmHg and without the occurrence of death amputation or repeat revascularization of the target lesion during the hospital stay
4 Acute technical success defined as the attainment of 50 residual stenosis by QA by any percutaneous method as determined by the angiographic core laboratory
5 The following endpoints at 30 days 6 12 24 and 36 months
Secondary Patency absence of restenosis which is defined as Duplex US PSVR 24
Change of Rutherford classification from baseline
Change of resting ankle-brachial index ABI from baseline
Change in walking impairment questionnaire from baseline
Change in six minute walk test from baseline
Secondary safety endpoints
1 Combined rate of death at 30 days target lesion revascularization TVR index limb amputation and increase in Rutherford-Becker Classification by 2 classes as compared to post-procedural assessment throughout 12 months
2 Stent fracture at 30 days 6 12 24 and 36 months Stent fractures will be analyzed by a two-view X-ray evaluation by a designated core laboratory compared with a baseline two-view X-ray taken before discharge and defined as type I II III IV or V as follows
Type I - a single strut fracture only
Type II - multiple single nitinol stent fractures that can occur at different sites
Type III - multiple nitinol stent fractures resulting in complete transverse linear fracture but without stent displacement
Type IV - a complete transverse linear type III fracture with stent displacement
Type V - a spiral dissection of a stent
3 Freedom at 30 days from all-cause death index limb amputation above the ankle and TVR
4 The following endpoints will be assessed at 30 days 6 12 24 and 36 months
1 All-cause death
2 Amputation above the ankle-Free Survival AFS
3 Target Vessel Revascularization TVR
4 Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature
5 Major Adverse Limb Events MALE at 30 days 6 12 24 and 36 months
1 Stent thrombosis
2 Clinically apparent distal embolization defined as causing end-organ damage eg lower extremity ulceration tissue necrosis or gangrene
3 Procedure-related arterial rupture
4 Acute limb ischemia
5 Target limb amputation
6 Procedure related bleeding event requiring transfusion
Sample Size and Statistical Analysis
The study is an early feasibility study and is not powered towards finding significant differences in the primary endpoints The sample size of up to 30 patients will allow for the evaluation of feasibility and safety of the procedure to support the initiation of a pivotal study No formal statistical power calculations were conducted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None